Agricultural Intervention for Food Security and HIV Health Outcomes in Kenya

NCT ID: NCT02815579

Last Updated: 2024-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 746 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2019-12-31

Brief Summary

The purpose of this study is to determine whether this multisectoral agricultural and microcredit loan intervention improves food security, prevent antiretroviral treatment failure, and reduce co-morbidities among people living with HIV/AIDS.

Detailed Description

Despite major advances in care and treatment for those living with HIV, morbidity and mortality among people living with HIV/AIDS (PLHIV) remains unacceptably high in sub-Saharan Africa (SSA), largely due to the parallel challenges of poverty and food insecurity.[1] In the Nyanza Region of Kenya, 15.1% of the adult population is infected by HIV,[2] and over 50% of the rural population is food insecure, primarily due to unpredictable rainfall and limited irrigation.[3,4] The investigators have previously shown that food insecurity delays antiretroviral therapy (ART) initiation, reduces ART adherence, contributes to worse immunologic and virologic outcomes, and increases morbidity and mortality among PLHIV.[5-16] There has been increasing international recognition that improved food security and reduced poverty are essential components for a successful global response to the HIV epidemic.[17-21] Yet, to date few studies have systematically evaluated the impacts of sustainable food security interventions on health, economic, and behavioral outcomes among PLHIV. Agricultural interventions, which have potential to raise income and bolster food security, are an important but understudied route through which to sustainably improve nutritional and HIV outcomes in SSA, including Kenya where agriculture accounts for > 75% of the total workforce, and 51% of the gross domestic product.[22]

Building on the investigators successful completion of the pilot intervention trial in Kenya and the investigators collective experience studying structural barriers to HIV care in SSA, the investigators plan to test the hypothesis that a multisectoral agricultural and microcredit loan intervention will improve food security, prevent ART treatment failure, and reduce co-morbidities among PLHIV. The investigators' intervention was co-developed with KickStart, a prominent non-governmental organization (NGO) based in SSA that has introduced a human-powered pump, enabling farmers to grow high yield crops year-round. This technology has reduced food insecurity and poverty for 800,000 users in 22 countries in the subcontinent since 1991.[23] The investigators' intervention includes: a) a loan (~$175) from a well-established Kenyan bank for purchasing agricultural implements and commodities; b) agricultural implements to be purchased with the loan including the KickStart treadle pump, seeds, fertilizers and pesticides; and c) education in financial management and sustainable farming practices occurring in the setting of patient support groups. This study is a cluster randomized controlled trial (RCT) of this intervention with the following specific aims:

Aim 1: To determine the impact of a multisectoral agricultural intervention among HIV-infected farmers on ART on HIV clinical outcomes. The investigators hypothesize that the intervention will lead to improved viral load suppression (primary outcome) and changes in CD4 cell count, physical health status, WHO stage III/IV disease, and hospitalizations (secondary outcomes) in the intervention arm compared to the control arm.

Aim 2: To understand the pathways through which the multisectoral intervention may improve HIV health outcomes. Using the investigator's theoretical model,[1,24] the investigators hypothesize that the intervention will improve food security and household wealth, which in turn will contribute to improved outcomes through nutritional (improved nutritional status measured with Body Mass Index), behavioral (improved ART adherence, and retention in care), and mental health (improved mental health/less depression, improved empowerment) pathways (secondary outcomes).

Aim 3: To determine the cost-effectiveness of the intervention and obtain the information necessary to inform scale-up in Kenya and similar settings in SSA. The investigators will quantify the cost per disability-adjusted life year averted, and identify lessons to inform successful scale-up.

To accomplish Aims 1 & 2, the investigators will randomize 8 matched pairs of health facilities in the Nyanza Region in a 1:1 ratio to the intervention and control arms, and enroll 44 participants per facility (total n=704). All participants will be followed for 2 years. Impacts of the investigator's intervention on primary health outcomes and mediators will be investigated to provide definitive data of direct and indirect intervention effects. To accomplish Aim 3, the investigators will: a) conduct a cost-effectiveness analysis; b) identify the characteristics of individuals most likely to benefit from the intervention (e.g., gender, educational attainment, family size, wealth, risk tolerance, and entrepreneurial ability); and c) perform a mixed-methods process evaluation with study participants, staff, and various stakeholders to determine what worked and did not work to guide future scale-up efforts of the intervention.

The investigator's ultimate goal is to develop and test an intervention to reverse the cycle of food insecurity and HIV/AIDS morbidity and mortality in SSA.

Conditions

HIV

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Intervention

The Shamba Maisha Intervention includes: a) a loan (\~$175) from a well-established Kenyan bank for purchasing agricultural implements and commodities; b) agricultural implements to be purchased with the loan including the KickStart treadle pump, seeds, fertilizers and pesticides; and c) education in financial management and sustainable farming practices occurring in the setting of patient support groups.

Group Type: EXPERIMENTAL

Shamba Maisha Intervention

Intervention Type: OTHER

A) A loan (\~$175) B) Agricultural implements to be purchased with the loan C) Education in financial management and sustainable farming practices

Control

Participants in the control arm will receive the standard of care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Shamba Maisha Intervention

A) A loan (\~$175) B) Agricultural implements to be purchased with the loan C) Education in financial management and sustainable farming practices

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• HIV-infected adults
• Currently receiving ART
• Belong to a patient support group or demonstrate willingness to join a support group
• Agree to save the down payment (~$10) required for the microcredit loan
• Have evidence of moderate to severe food insecurity based on the Household Food Insecurity Access Scale (HFIAS), and/or malnutrition (BMI<18.5) based on FACES medical records during the year preceding recruitment
• Have access to farming land and available surface water in the form of lakes, rivers, ponds and shallow wells

Exclusion Criteria

• People who do not speak Dholuo, Swahili, or English
• Inadequate cognitive and/or hearing capacity to complete planned study procedures, at the discretion of the research assistant

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Kenya Medical Research Institute

OTHER

Sponsor Role: collaborator

University of South Carolina

OTHER

Sponsor Role: collaborator

University of Connecticut

OTHER

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sheri D Weiser, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Departments of Medicine, UCSF

Craig R Cohen, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Department of Obstetrics, Gynecology & Reproductive Sciences, UCSF

Locations

Kitare

Suba, Homa Bay County, Kenya

Sindo

Suba, Homa Bay County, Kenya

Muhuru Bay

Nyatike, Migori County, Kenya

Sori Lakeside

Nyatike, Migori County, Kenya

Minyenya

Rongo, Migori County, Kenya

Ngode

Rongo, Migori County, Kenya

Oyani

Rongo, Migori County, Kenya

Nyamasare

Uriri, Migori County, Kenya

Hongo Ogosa

Kisumu, , Kenya

Kisumu District Hospital

Kisumu, , Kenya

Lumumba

Kisumu, , Kenya

Nyangande

Kisumu, , Kenya

Pandiperi

Kisumu, , Kenya

Railways

Kisumu, , Kenya

Osingo

Migori, , Kenya

Suna Ragana

Migori, , Kenya

Countries

Kenya

References

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Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

R01MH107330-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

P0503135

Identifier Type: -

Identifier Source: org_study_id